Softcup Box of Softcup 14 count (English only)Recalls & reported problems
The Flex Company · Box of Softcup/Softdisc 14 count (English only) · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00851906007033), received between Jan 5, 2025 and Jan 5, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Difficult to Remove” (1 report).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Most reported problems
Device problems
- Difficult to Remove1
- Patient Device Interaction Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 5, 2025Difficult to Remove; Patient Device Interaction Problem; Difficult to Remove; Patient Device Interaction Problem
CUSTOMER REPORTED GOING TO URGENT CARE FOR ASSISTANCE WITH REMOVAL OF SOFTDISC DISPOSABLE MENSTRUAL DISC. THE DISC HAD BEEN INSERTED FOR 18 HOURS WHEN THE CUSTOMER SOUGHT ASSISTANCE. THE CUSTOMER STATED THAT THE PHYSICIAN'S ASSISTANT (PA) STRUGGLED TO REMOVE THE DISC. THE PA UNSUCCESSFULLY TRIED REMOVING THE DISC WITH A SPECULUM AND FORCEPS BEFORE THEN PUSHING ON THE CUSTOMER'S ABDOMEN AND SUCCESSFULLY REMOVING THE DISC DIGITALLY. THE PA DETERMINED THE DISC WAS SUCTIONED TO THE CUSTOMER'S CERVIX. THE CUSTOMER STATED SHE FELT "INTERNALLY AND EXTERNALLY BRUISED" FROM THE ASSISTED REMOVAL, BUT ALSO SAID SHE DID NOT HAVE PAIN/DISCOMFORT POST REMOVAL. THE CUSTOMER WAS NOT PRESCRIBED ANY MEDICATION. THE CUSTOMER WAS ADVISED BY FLEX TO DISCONTINUE USE OF ALL INTERNALLY WORN FLEX PRODUCTS UNTIL THEY CAN FOLLOW UP WITH THEIR PRIMARY HEALTHCARE PROVIDER TO DISCUSS THEIR EXPERIENCE. THE SUBMISSION OF THIS REPORT IS NOT AN ADMISSION BY THE COMPANY THAT THE USE OF THE DEVICE IN QUESTION CAUSED OR CONTRIBUTED TO THE CUSTOMER EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21076519 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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